Studies show that bladder control problems, also called urinary incontinence (UI), affect up to 30 percent of women over 60 and 18% of men, affecting more than 13 million U.S. adults. In addition, 25% of women ages 30-59 have experienced an episode of urinary incontinence. Urinary incontinence is the medical term used to describe the condition whereby one cannot control the flow of urine from one's body. This can result in involuntary loss of urine that can be demonstrated objectively and which constitutes a medical, social or hygienic problem. Urinary incontinence can be caused by a number of problems, including: mixed incontinence (used to describe patients, mainly women, who suffer from symptoms of both urge and stress incontinence), overactive bladder (involuntary contractions of the detrusor muscle of the bladder), sphincter abnormalities (stress incontinence—the involuntary loss of urine at a sudden increase in the abdominal pressure that occurs when the pressure within the bladder exceeds the maximum closure pressure of the urethra in the absence of activity of the detrusor muscle), and urge incontinence (associated with a sensation of urgency). Bladder control problems should never be accepted as a normal part of aging. Though it is readily diagnosed, most people do not discuss the symptoms of Urinary incontinence with their physicians. This is partly out of embarrassment or believing that it is a normal part of child bearing or aging, thus, many patients may not get treatment. Those that do, may not experience a cure, but may be too embarrassed to return or may decide to live with the discomfort rather than to try a further treatment.
Urinary incontinence is often described as loss of bladder control. However, it is not the bladder which is controlling the flow of urine. The bladder functions to collect and store urine. A circular muscle called the sphincter actually controls the flow of urine out of the bladder. Urinary incontinence usually happens because of many different factors, most of which are still unknown. But, it is believed that the end result is an increase in intravesical pressure that exceeds that of the urethral pressure and causes involuntary loss of urine. One cause may be a damaged sphincter which cannot squeeze and close off the urethra. In men, the sphincter is located below and above the prostate, and the prostatic smooth muscle is also intertwined with the whole sphincter mechanism. Another cause may be a damaged sphincter which cannot squeeze and close off the urethra.
Many of the methods used to surgically treat urinary incontinence rely on implanting a device into the tissue to restrict or constrict the urethra of the patient to maintain continence. Typically, the placement of the device will decide the level of continence after surgery. However, these devices/grafts are prone to being under- or over-inflated/stretched at the time of implant, leading to undesirable postoperative results. For example, if the devices/grafts are over-inflated/stretched and cause the urethra to be restricted too tightly, the patient is at risk for retention, a condition where the patient cannot pass urine. Such a condition could lead to kidney damage, necessitating major corrective surgery or at minimum use of self-catheterization to empty the bladder on a regular basis thus increasing the risk of urinary tract infection. Excessive occlusive forces are known to undesirably minimize arteriovascular blood flow to the urethra and thereby increase the possibility of ischemia and erosion to the delicate tissues.
Alternatively, if the devices/grafts are under-inflated/stretched or in some other way cause the urethra to be restricted too loosely, the patient still suffers from urinary incontinence. In addition, many of the previous devices and methods allow for a small amount of leakage. However, once the surgery is completed, there is no readily available means without additional surgery to accurately and continuously adjust the occlusive pressures which are applied to the urethra, or other lumen by the device or method, to achieve continence, or the correct amount of pressure.
More particularly, because of the swollen and aggravated condition of edema of the urethral tissues during and for a period subsequent to surgery, the physician cannot be certain as to the normalized condition of the patient's urethra until post-operative edema has subsided. Therefore, the physician must estimate the required minimal occlusive force needed to achieve continence. There is no data available in the literature to this date as to what degree these occlusive pressures should be at any given time. Thus, as a consequence of the need to estimate, sphincteric mechanisms and other devices are often improperly fitted or selected. Moreover, where conventional mechanisms include occlusive force control means, such force control is usually accomplished in large, step-wise increments. Therefore no artificial sphincters are known which are adapted to easily and accurately control or continuously vary the occlusive pressures needed to achieve continence, so that the sphincter may be percutaneously tailored to the individual needs of the patient on an ongoing basis without requiring additional surgery. In particular, no methods are available which can be controlled by the patient.
Thus, a method for the surgical treatment of Urinary Incontinence is needed which is simple, adjustable over time or as healing occurs, and results in a higher patient satisfaction. Preferably, the method of insertion is also less invasive and could eventually become an office procedure.